BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRETZELFLEX 3MM DEVICE

    MDR report key: 4593680 · Received January 20, 2015

    Report

    Report Number
    9680952-2014-00001
    Event Type
    Malfunction
    Date Received
    January 20, 2015
    Date of Event
    November 17, 2014
    Report Date
    January 8, 2015
    Manufacturer
    SURGICAL INNOVATIONS LTD
    Product Code
    GCJ
    PMA / PMN Number
    K112659
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, ONLY LIMITED INFO HAS BEEN PROVIDED BY THE DISTRIBUTOR AND ALSO IN RELATION TO THE CONDITION OF THE PT. A REQUEST HAS ALREADY BEEN MADE ON 01/07/2015 FOR ADD'L INFO. THE DEVICE US AVAILABLE FOR EVAL AND THE DISTRIBUTOR IS CURRENTLY IN THE PROCESS OF ARRANGING THE DEVICE TO BE RETURNED TO THE MFR FOR EVAL.

    Description of Event or Problem · 1

    THE CUSTOMER (CAREFUSION) REPORTED THE FOLLOWING COMPLAINT IN RELATION TO THE 3MM PRETZELFLEX DEVICE; PART NUMBER: 89-6133, LOT NUMBER: 65933. THE CUSTOMER REPORTED: "THE DEVICE FELL APART, THE INSTRUMENT BROKE INSIDE A PT DURING A PROCEDURE ON (B)(6) 2014. ALL THE PIECES FROM THE DEVICE WERE RECOVERED". THE DEVICE IS AVAILABLE FOR EVAL AND HAS BEEN DECONTAMINATED. BECAUSE THIS IS A MDR COMPLAINT, OUR PROCEDURES REQUIRED A WRITTEN EVAL FROM YOU, OUR SUPPLIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44778 PRETZELFLEX 3MM DEVICE PRETZELFLEX 3MM DEVICE GCJ SURGICAL INNOVATIONS LTD 65933

    Patients

    Seq Age Sex Outcome Treatment
    1